Drainage bag systems including at least one indicator element and methods of using the same

ABSTRACT

Embodiments disclosed herein relate to drainage bag systems (e.g., catheterization and urine drainage bag systems) including at least one indicator element that may indicate that one or more patient care protocols were performed. For example, the drainage bag system includes a drainage bag including at least one indicator element (e.g., calendar, checklist, combinations thereof, etc.) configured to provide information indicating that the one or more patient care protocols were performed, such as verifying compliance with the one or more patient care protocols.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.15/324,114 filed on 5 Jan. 2017, which is a US Nationalization of PCTInternational Application No. PCT/US2016/015795 filed on 29 Jan. 2016,which claims priority to U.S. Provisional Application No. 62/111,088filed on 2 Feb. 2015 and U.S. Provisional Application No. 62/249,752filed on 2 Nov. 2015. The disclosure of each of the foregoingapplications is incorporated herein, in its entirety, by this reference.

BACKGROUND

Generally, urinary catheterization involves insertion of a urinarycatheter (e.g., a tube) through a patient's urethra into a bladder. Theurinary catheter (e.g., a Foley urinary catheter) allows the patient'surine to drain from the bladder through a drainage tube into a drainagebag.

In some instances, a care provider may have protocols related to patientcare during and/or after the patient's catheterization. However, suchpatient care protocols may be inconsistently performed and/or performedinaccurately. Improving compliance with such patient care protocols mayimprove patient care and/or reduce complications related to thepatient's catheterization (e.g., catheter-associated urinary tractinfection).

Accordingly, manufacturers and users of catheterization systems andmethods continue to seek improvements thereto.

SUMMARY

Embodiments disclosed herein relate to drainage bag systems (e.g.,catheterization and urine drainage bag systems) including at least oneindicator element that may indicate that one or more patient careprotocols were performed. For example, the drainage bag system includesa drainage bag including at least one indicator element (e.g., calendar,checklist, combinations thereof, etc.) configured to provide informationindicating that the one or more patient care protocols were performed,such as verifying compliance with the one or more patient careprotocols.

In an embodiment, a drainage bag system is disclosed. The drainage bagsystem includes a drainage bag. The drainage bag includes an inletconfigured to receive a fluid from a patient. The drainage bag alsoincludes one or more panels defining an interior space configured tohold the fluid therein. The drainage bag system further includes atleast one indicator element. The at least one indicator element includesone or more indicator sites thereon. Each of the one or more indicatorsites includes at least one of a blank or unfilled location.

In an embodiment, a method of using a drainage bag is disclosed. Themethod includes providing a drainage bag system to be operably connectedto a patient. The drainage bag system includes the drainage bag definingan interior space configured to contain fluid. The drainage bag systemalso includes at least one indicator element including one or moreindicator sites thereon. Each of the one or more indicator sitesincludes at least one of a blank or unfilled location. The methodfurther includes performing one or more patient care protocols on thepatient that is related to using the drainage bag with the patient. Themethod additionally includes marking the one or more indicator sites toshow that the one or more patient care protocols were performed.

Features from any of the disclosed embodiments may be used incombination with one another, without limitation. In addition, otherfeatures and advantages of the present disclosure will become apparentto those of ordinary skill in the art through consideration of thefollowing detailed description and the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

For better understanding, the like elements have been designated by likereference numbers throughout the various accompanying figures.Understanding that these drawings depict only typical embodiments of thepresent disclosure and are not therefore to be considered to be limitingof its scope, the embodiments of the present disclosure will bedescribed and explained with additional specificity and detail throughthe use of the accompanying drawings in which:

FIG. 1A is a top plan view of a drainage bag system that includes adrainage bag having at least one indicator element in an inactive state,according to an embodiment;

FIG. 1B is a top plan view of the drainage bag system shown in FIG. 1Ahaving an indicator element in an active state, according to anembodiment;

FIG. 1C is a top plan view of a package that may form a portion of thedrainage bag system shown in FIG. 1A, according to an embodiment;

FIG. 1D is a top plan view of a package that may form a portion of thedrainage bag system shown in FIG. 1A, according to an embodiment;

FIG. 2 is a top plan view of a drainage bag system that includes adrainage bag with a plurality of indicator elements, according to anembodiment;

FIG. 3 is a top plan view of a kit that includes a drainage bag and atleast one token, according to an embodiment;

FIGS. 4A-4D are isometric views of indicator elements that are distinctand separate from a drainage bag, according to various embodiments; and

FIG. 5 is a side view of a drainage bag system including a drainage bagand a plurality of packages removably attached together, according to anembodiment.

DETAILED DESCRIPTION

Embodiments disclosed herein relate to drainage bag systems (e.g.,catheterization and urine drainage bag systems) including at least oneindicator element that may indicate that one or more patient careprotocols were performed. For example, the drainage bag system includesa drainage bag including at least one indicator element (e.g., calendar,checklist, combinations thereof, etc.) configured to provide informationindicating that the one or more patient care protocols were performed,such as verifying compliance with the one or more patient careprotocols.

The indicator element of the drainage bag may be in a first or aninactive state (e.g., during initial deployment of the drainage bag).The indicator element may be reconfigured into a second or active state,to provide information related to the patient's care, status of theurine drainage bag, etc. For example, in the active state, the indicatorelement may provide or display information related to one or morepatient care protocols. Such information may include one or more of adate of deployment of the drainage bag, a date of insertion of acatheter operably connected to the drainage bag, date(s) and/orperformance of the one or more patient care protocols, etc., which maybe required and/or recommended by the one or more patient careprotocols.

The indicator element of the drainage bag may be reconfigured from theinactive state to the active state in a manner that facilitatesauthentication of the accuracy of the information related to patientcare protocols provided or displayed by the at least one indicatorelement and/or prevents tampering therewith (e.g., compliance indicatorelements). In an embodiment, the indicator element may be reconfiguredfrom the inactive state into the active state using a specific and/orunique token. For example, the token may become available to the user(e.g., a medical practitioner) after starting or completing apredetermined task or sequence of tasks.

The one or more patient care protocols may vary depending on theapplication of drainage bag system (e.g., collect urine, blood, stool,etc.) and the specific needs of the patient. In an embodiment, thedrainage bag may include a urine drainage bag. In such an embodiment, atleast some of the patient care protocols may be configured to complywith the Center of Disease Control's (“CDC”) “Guideline for Preventionof Catheter Associated Urinary Tract Infections” released in 2009 andavailable athttp://www.cdc.gov/hicpac/pdf/CAUTI/CAUTIguideline2009final.pdf, thedisclosure of which is incorporated herein, in its entirety, by thisreference. For example, the one or more patient care protocols verifiedby the at least one indicator element of the urine drainage bag mayinclude one or more of the following: periodic cleaning of the perinealregion of the patient, periodic cleaning of the periurethral region ofthe patient, periodic cleaning of a portion of the drainage bag system(e.g., about every 12 hours), routine removal of urine from the drainagebag, inspections of the drainage bag system to check for leaks, kinks,etc., proper hand hygiene when manipulating the drainage bag system, orproper aseptic techniques performed while inserting the urinarycatheter.

The drainage bag systems disclosed herein are described as being urinarydrainage bag systems. However, the drainage bag systems disclosed hereinmay be used in any drainage bag system that collects fluid from apatient. For example, any of the drainage bag systems disclosed hereinmay be used in a blood drainage system, a pleural drainage system, aperitoneal drainage system, a bowel drainage system (e.g., a stoolcollection bag), or another suitable drainage system.

FIG. 1A is a top plan view of a drainage bag system 100 that includes adrainage bag 102 having at least one indicator element 104 in aninactive state, according to an embodiment. The drainage bag 102includes a front panel 106 and a back panel bonded together to form afluid tight container. However, in other embodiments, the drainage bag102 may include and/or may be formed by three or more panels, or asingle body. The one or more panels may define an interior spaceconfigured to hold a fluid (e.g., urine) therein. In an embodiment, aprivacy barrier (not shown) may be provided that is integrally formedwith the drainage bag 102, attached to the drainage bag 102, or separatefrom the drainage bag 102, which is at least substantially opaque andconfigured to cover at least a portion of the drainage bag 102 (e.g.,obscure the at least a portion of an interior space of the drainage bag102 from view such as obscuring and/or concealing urine in the drainagebag 102). Moreover, it should be appreciated that the one or more panelsof the drainage bag 102 may include flexible, rigid, resilient, or anysuitable material or combinations of materials. In any event, the panelsof the drainage bag 102 may be connected and/or bonded together in amanner that forms or defines the interior space of the drainage bag 102,which may contain fluid therein.

Generally, the drainage bag 102 may have any suitable geometry. In theillustrated embodiment, the drainage bag 102 has a generally tear-shapedgeometry. However, the drainage bag 102 may have a generally circulargeometry, a generally rectangular geometry, etc.

The drainage bag 102 may also include an inlet 110, which may beconfigured to accept a fluid flow from the patient (e.g., urine) intothe drainage bag 102. For example, the inlet 110 may receive or connectto a drainage tube 112 that may be in fluid communication with acatheter 114 that, for example, may be positioned in a patient'sbladder. In the illustrated embodiment, the catheter 114 may include aFoley urinary catheter, such that urine may flow into the drainage bag102 from the catheter 114 and through the drainage tube 112.

In an embodiment, the drainage bag 102 may include an outlet 116 (e.g.,at or near a bottom of the drainage bag 102). For example, the outlet116 may be configured to allow a fluid collected in the drainage bag 102to flow or drain from the drainage bag 102 (e.g., for collecting orextracting the fluid from the drainage bag 102). For example, the outlet116 may include the Safety-Flow™ outlet device or another similar outletdevice.

The front panel 106 of the drainage bag 102 may further include one ormore graduated markings 118 that may indicate an amount of a fluidcollected in the drainage bag 102. For example, the graduated markings118 may facilitate determining the amount of fluid discharged by thepatient in a time span (e.g., predetermined time span). In someembodiments, the graduated marking 118 may facilitate determining orapproximating a time and/or date for draining, removing, and/or changingout the drainage bag 102.

The indicator element 104 may be configured to show completion of a task(e.g., a patient care protocol) related to the drainage bag system 100.For example, the indicator element 104 may be marked by a user to showthat a task has been performed. In an embodiment, the indicator element104 may be a compliance indicator element configured to ensurecompliance with one or more patient care protocols. For example, theindicator element 104 may include a type identifier 120 that providesgeneral information to the user. The indicator element 104 may alsoinclude one or more indicator sites 122 that are marked by a user. Forexample, the indicator sites 122 may be configured to verify compliancewith the one or more patient care protocols (e.g., compliance indicatorsites).

The type identifier 120 may provide information related to the drainagebag 102 and/or patient care. For example, the type identifier 120 mayinclude information related to the patient (e.g., the patient's name,the procedure performed on the patient, etc.), information related tothe caregiver (e.g., the responsible physician's name, the responsiblenurse's name, etc.), the catheter 114 insertion date, etc. The typeidentifier 120 may also identify what patient care protocols are beingindicated as having been performed and/or verified by the indicatorsites 122. The type identifier 120 is not configured to verifyperformance of the one or more patient care protocols.

In an embodiment, the type identifier 120 may be configured to be markedby a user. For example, the type identifier 120 may include a surfacethat is configured to be marked using writing utensils, receive a token(e.g., sticker, stamp, etc.), or other suitable forms of input. Markingthe type identifier 120 may enable the indicator element 104 to displayinformation that may be unique to each individual drainage bag 102. Insome embodiments, at least a portion of the type identifier 120 may bepreprinted. The preprinted portions may include information related tothe patient care protocols tracked by the indicator sites 122 and/orfacilitate marking the type identifier 120. For example, the preprintedportions of the type identifier 120 may include the phrase “InsertionDate:”, “Patient Name:”, “Physician;” similar phrases, or combinationsthereof. Adjacent to the preprinted portions, the type identifier 120may include a surface configured to receive input from the user.

In an embodiment, the type identifier 120 may include labeling (notshown) that facilitates performance and standardization of the one ormore patient care protocols verified by the compliance indicator sites.The labeling may include step-by-step instructions and/or pictographsdetailing how to perform the one or more patient care protocols verifiedby the compliance indicator sites. The labeling may conform to patientcare protocols promulgated by the CDC, individual hospitals, or otherhealthcare organizations. Having the instructions included in the typeidentifier 120 may help standardize the one or more patient careprotocols, prevent a user (e.g., a physician, nurse, certified nurse'sassistant, etc.) from incorrectly performing the one or more patientcare protocols, refresh the user's memory on how to correctly performthe one or more patient care protocols, etc. As such, the labeling mayfurther verify compliance with the one or more patient care protocols.

The indicator sites 122 may be configured to be marked by a user toindicate that a task related to the drainage bag system 100 has beperformed. For example, the indicator sites 122 may be complianceindicator sites configured to verify compliance with one or more patientcare protocols. Each of the indicator sites 122 may include a blank orunfilled location that corresponds to one or more patient care protocolsthat may be performed. The blank or unfilled locations may be configuredto be marked by a user, for example, when one or more patient careprotocols are performed. For example, the blank or unfilled locationsmay be marked just before, during, or after the one or more patient careprotocols are performed. As such, the indicator sites 122 may beconfigured to be marked using a writing utensil, at least one token, oranother suitable form of input. As such, marking the indicator sites 122may indicate and verify compliance with a patient care protocol (e.g.,compliance indicator sites).

In some embodiments, the indicator sites 122 may include one or moremarkings thereon (e.g., preprinted thereon) configured to facilitatemarking by the user. For example, the indicator sites 122 may include abox defining at least one indicator site 122, an underlined portionindicating where to mark, one or more phrases (e.g., “_/_/20__”indicating a date to be marked), etc.

In the illustrated embodiment, the indicator sites 122 at leastpartially form a calendar 123 (e.g., an indicator displaying one or moredates). In an embodiment, the calendar 123 may be configured to verifycompliance with one or more patient care protocols. For example, each ofthe of the indicator sites 122 may be compliance indicator sites thatmay correspond to a date (e.g., calendar date), day (e.g., number ofdays after an event), and/or time that the one or more patient careprotocols are to be performed and/or verify when the one or more patientcare protocols are performed. In the illustrated embodiment, thecalendar 123 has less than 31 indicator sites 122 (e.g., less than 30indicator sites 122). However, in other embodiments, the calendar 123may include at least 30 indicator sites 122 (e.g., 31 indicator sites122) to correspond to each day of a given month of a year. The indicatorsites 122 may at least partially form the calendar 123 if the one ormore patient care protocols are to be performed at certain timeintervals, on certain dates and/or times; or it is desirable to trackthe performance of the one or more patient care protocols over a periodof time. Such patient care protocols may include, for example, washingthe perineal and/or periurethral region of the patient if the drainagebag 102 is used with the urinary catheter 114, periodic inspections ofthe drainage bag system 400 by the user, etc.

In an embodiment, at least some of the dates provided on the calendar123 may exhibit different colors. For example, the calendar 123 mayinclude a first time period (e.g., including one or more days) thatexhibits a first color and a second time period that exhibits a secondcolor. In an embodiment, the different colors may be used to indicatewhen the catheter 114 (e.g., the catheter 114 that operably connected tothe drainage bag 102) should be removed from the patient. For example,the first time period of the calendar 123 may represent the CDC' srecommend time period that the catheter 114 is inserted into the patient(e.g., about one to three days). The calendar 123 may also include asecond time period immediately after the first time period that exhibitsa different color than the first time period. As such, the second timeperiod may indicate that the CDC recommends removing the catheter 114from the patient. Additionally, the calendar 123 may include one or moreadditional time periods immediately after the second time period thatexhibit a color that is different than the first time period and thesecond time period. In other embodiments, the one or more colors mayindicate time periods within which one or more specific patient careprotocols may be performed, when the one or more patient care protocolschange, etc.

In an embodiment, the indicator element 104 may initially be in aninactive state (FIG. 1A). The indicator element 104 is considered to bein an inactive state when the type identifier 120 and/or each indicatorsite 122 include a blank or unfilled location. For example, the typeidentifier 120 that is in an inactive state does not provide anyinformation and instead merely provides a location to receive input.Similarly, the indicator sites 122 that are in an inactive state merelyprovide locations that are configured to be marked by the user and/orindicate that no patient care protocols have been performed.

However, the indicator elements 104 may be reconfigured from an inactivestate to an active state when the type identifier 120 and/or at leastone of the indicator sites 122 are marked by the user. FIG. 1B is a topplan view of the drainage bag system 100 shown in FIG. 1A having theindicator element 104 in an active state, according to an embodiment. Assuch, when the indicator element 104 is in an active state, the typeidentifier 120 may provide general information about the drainage bag102 and/or patient care while the indicator sites 122 may indicate thata task related to the drainage bag system 100 has been performed (e.g.,verify compliance with one or more patient care protocols and/or thatone or more patient care protocols have been performed). For example, inthe illustrated embodiment, the indicator sites 122 includes complianceindicator sites in an active state that show that patient care protocolshave been performed at least three times over a two day period. However,the illustrated indicator sites 122 include compliance indicator sitesthat also show that at least one patient care protocol may not have beenperformed. In some embodiments, the type identifier 120 may initially bein an active state. For example, all the information provided by thetype identifier 120 may be preprinted on the indicator element 104.

The indicator sites 122 may be configured to be marked by the user usingdifferent mechanisms. In an embodiment, the indicator sites 122 mayinclude or provide one or more locations (e.g., surfaces) that may bemarked using at least one writing utensil (e.g., marker, etc.). Forexample, the indicator sites 122 may include paper or another surfacethat may be marked mark by the writing utensil. The indicator sites 122may be configured to be marked in a specific manner, such as with a dateor a symbol identifying the user (e.g., signature, initials, etc.). Insome embodiments, the indicator sites 122 may be include material thatmay only be marked using a specific writing utensil. For example, theindicator sites 122 may include one or more dark or black locations,which may accept markings from a light-colored writing utensil.

Alternatively or additionally, the indicator sites 122 may be configuredto be marked using at least one token 126 (see FIG. 1B and 1C). Thetoken 126 may be any suitable identifying marking that may be placed,attached, stamped, or otherwise imposed on the indicator sites 122. Forexample, the token 126 may be a sticker, a stamp, paper, etc. thatincludes an adhesive thereon that adheres to the drainage bag 102. Insome embodiments, the token 126 may be a specific token. For example,the token 126 may exhibit a specific size, shape, color, or combinationsthereof; and/or may have a specific symbol printed thereon (e.g., auser's name) In some embodiments, the token 126 may only be accessed atcertain times, thereby reducing or eliminating incorrect or backdatedmarkings on the indicator element 104.

The indicator element 104 may be positioned on the drainage bag 102. Forexample, the drainage bag 102 may have a geometry that includes orprovides a suitable location for the indicator element 104. For example,the indicator element 104 may be placed in a location that may not becovered or obscured by the inlet 110, the outlet 116, the drainage tube112, or any other device of the drainage bag system 100. Additionally oralternatively, the indicator element 104 may be spaced or distanced fromthe graduated markings 118.

In any event, the indicator element 104 may be located on any panel orportion of the drainage bag 102. For example, the indicator element 104may be attached to the front panel 106, the back panel, or the privacybarrier. Moreover, it should be appreciated that references to the frontpanel 106 and back panel of the drainage bag 102 are made for ease ofdescription, and either panel of the drainage bag 102 may be consideredas the front or back panel thereof. In the illustrated embodiment, theindicator element 104 may be located on the front panel 106 of thedrainage bag 102. For example, the indicator element 104 may provideinformation to the user if the front panel 106 of the drainage bag 102is generally facing the user. In alternative or additional embodiments,the drainage bag 102 may include multiple indicator elements (e.g., theindicator element 104 may be provided or included on the front panel 106and another indicator element may be included on the back panel of thedrainage bag 102), which may increase the likelihood that at least oneof the indicator elements will generally face the user under some useconditions.

The indicator element 104 and/or portions thereof may have any numbersuitable sizes or dimensions, which may vary from one embodiment to thenext. In some embodiments, the indicator element 104 may have relativelylarge dimensions, which may improve visibility thereof from a distance.In other embodiments, one or more portions of the indicator element 104may have relatively small dimensions, which may facilitate display ofadditional information (as compared with the larger indicator element orcorresponding portions thereof). In an embodiment, the indicator element104 may be configured to provide or display (e.g., to a user, such as ahealth care provider) information related to one or more patient careprotocols.

In an embodiment, one or more portions or elements of the indicatorelement 104 may be preprinted on, attached to, or secured to thedrainage bag 102. For example, at least a portion of the type identifier120 and/or the indicator sites 122 may be printed on the front panel106, the back panel, and/or the privacy barrier of the drainage bag 102.In other embodiments, at least a portion of the indicator element 104(e.g., at least one of the type identifier 120 and/or indicator sites122) may be printed on a device (e.g., paper, sticker, stamp, etc.) thatis attached to the front panel 106, the back panel, or the privacybarrier of the drainage bag 102. The device that includes at least aportion of the indicator element 104 may be provided from, for example,a package 124 (FIG. 1C). For example, the drainage bag system 100 maynot initially include the indicator element 104 and the indicatorelement 104 is added to the drainage bag system 100 after the drainagebag system 100 is provided (e.g., after opening a kit, after insertionof the catheter 114, etc.)

In some embodiments, the drainage bag system 100 may include one or morepatient care protocol packages 124 (“packages”). FIG. 1C is a top planview of a package 124 that may form a portion of the drainage bag system100, according to an embodiment. The package 124 may include any device(e.g., token 126) that is configured to perform, verify, and/or assistat least one of the one or more patient care protocols or the device maybe omitted. In an embodiment, the package 124 may be configured toperform and/or assist at least one of the one or more patient careprotocols that are verified by the indicator sites 122 (e.g., complianceindicator sites). For example, in the illustrated embodiment, thepackage 124 is a wipe container. The wipes present in the package 124may be used to wash one or more regions of the patient and/or one ormore portions of the drainage bag system 100 according to one or morepatient care protocols. The package 124 may include other devices, suchas syringes used to remove fluid from the drainage bag 102, a containerincluding gloves therein, or combinations thereof.

In some embodiments, the package 124 may include at least one token 126associated (e.g., attached to, positioned within, incorporated into,etc.) therewith. For example, the at least one token 126 may bepositioned on a surface of the package 124. The token 126 is configuredto be removed from the package 124 and attached to the indicator sites122. Positioning the token 126 on the package 124 permits the user toonly have access to the token 126 just before, during, and for a shortperiod of time after one or more patient care protocols are performed.Restricting the time period during which the user has access to and canmark the indicator sites 122 with the token 126 may further verifycompliance with the one or more patient care protocols (e.g., complianceindicator sites). In particular, restricting when a user has access tothe token 126 reduces or eliminates incorrect or backdated markings ofthe compliance indicator sites.

In an embodiment, the token 126 may be positioned on the surface of thepackage 124 such that the token 126 acts as a tamper proof seal. Forexample, the token 126 may straddle and/or cover a portion of anexterior surface of the package 124 that is configured to grant accessto an interior region of the package 124 or be otherwise used. As such,an at least partially torn token 126 or a missing token 126 may indicatethat the package 124 may have been tampered with.

In some embodiments, the indicator sites 122 may be configured toreceive the token 126 from the package 124. For example, the indicatorsites 122 may exhibit a size and/or shape that correspond to the sizeand/or shape of the token 126 on the package 124.

In an embodiment, the token 126 may be positioned within the package124. As such, the token 126 positioned within the package 124 may onlybe accessed after the package 124 is opened. For example, the token 126may be positioned under the wipes that are within the package 124 suchthat the token 126 may only be accessed after the wipes are removed fromthe package 124. The token 126 positioned within the package 124 may beused in conjunction with the token 126 positioned on the surface of thepackage 124. In other embodiments, at least one of the token 126positioned within the package 124 or the token 126 positioned on thesurface of the package 124 may be omitted.

In an embodiment, the package 124 may include labeling 128 thatfacilitates performance and standardization of the one or more patientcare protocols. In some embodiments, the labeling 128 may facilitatecorrect usage of the package 124 and correct performance of the one ormore patient care protocols that use the package 124. For example, thelabeling 128 may include step-by-step instructions and/or pictographsdetailing how to perform the one or more patient care protocols thatutilize the package and/or how to correctly use the package 124. Thelabeling 128 may conform to patient care protocols promulgated by theCDC, individual hospitals, other healthcare organizations, orcombinations thereof. Having the labeling 128 included on the package124 (e.g., preprinted on the package 124) may help standardize the oneor more patient care protocols that utilize the package 124, standardizethe operation of the package 124, prevent a user from incorrectlyperforming the one or more patient care protocols and/or incorrectlyusing the package 124, refresh the user's memory on how to correctly usethe package 124, etc. As such, the instructions may further verifycompliance with the one or more patient care protocols.

In an embodiment, the package 124 may further include the indicatorelement 104 therein or thereon. For example, the indicator element 104may include a sticker, a piece of paper, a postcard-like device, etc.that is attached to and/or positioned within the package 124. Theindicator element 104 may then be removed from the package 124 andattached to the drainage bag system 100, such as attached to thedrainage bag 102. For example, the indicator element 104 may be attachedto the front panel 106, the back panel, the privacy barrier, orotherwise associated with the drainage bag 102 (FIGS. 4A-4D). In anembodiment, the indicator element 104 may be attached to the drainagebag system 100 using an adhesive, a string, an elastic band, a clamp, oranother attachment method.

FIGS. 1A-1C also illustrate a method of using the drainage bag system100, according to an embodiment. Referring to FIG. 1A, the drainage bagsystem 100 may be provided, which may be configured to be used as aurinary drainage bag system including the catheter 114. In such anembodiment, the indicator element 104 may be configured to indicatecompletion of a task related to the drainage bag system 100 (e.g.,verify performance and/or compliance with one or more patient careprotocols related to pre-insertion of the catheter 114 and/orpost-insertion of the catheter 114). For example, the indicator element104 may include compliance indicator elements configured to verifycompliance with the post-insertion patient care protocol of washingportions of the periurethral and perineal regions of the patient, and/orwashing portions of the drainage bag system 100, in particular, portionsof the drainage bag system 100 positioned proximate the periurethral andperineal regions of the patient (“post-insertion patient careprotocol”). In some embodiments, the post-insertion patient careprotocol may be required to be performed about every 12 hours. As such,the indicator element 104 may include the calendar 123 where each dateon the calendar 123 includes two indicator sites 122 that correspond toone of the 12 hour periods. Initially, the indicator element 104 may beprovided in an inactive state.

Referring to FIG. 1C, in the illustrated embodiment, the package 124 maybe used to facilitate performance of a patient care protocol related tothe drainage bag system 100. In an embodiment, the package 124 may alsobe configured to verify compliance with a patient care protocol (e.g.,the post-insertion patient care protocol). For example, the package 124may include a container that includes wipes therein. In someembodiments, the post-insertion patient care protocol may require thatfive different portions of the patient's periurethral region, thepatient's perineal region, and the drainage bag system 100 be washedusing, for example, non-antiseptic wipes. As such, the package 124 mayinclude at least five different wipes therein, each wipe correspondingto a different portion of the patient's periurethral region, thepatient's perineal region, and the drainage bag system 100. An exampleof wipes that may be included in the package 124 include Provon®products available from GOJO.com.

The package 124 may include labeling 128 thereon that facilitatesperformance and standardization of the post-insertion patient careprotocol. For example, the illustrated labeling 128 may state that thefirst and second wipes present in the package 124 may be used to cleanthe genitalia of the male (e.g., wipe the foreskin and the meatus,foreskin, the periphery thereabout) and/or female (wipe the meatus). Thelabeling 128 may also state that the third and fourth wipe present inthe package 124 may be use to clean the inner thigh of the patient.Finally, the labeling 128 may state that the fifth wipe is used to cleana portion of the catheter 114. It is noted that the labeling 128 mayinstruct the user to perform the post-insertion patient care protocol ina different order, modify certain acts, and/or omit or add certain acts.For example, the labeling 128 may instruct the user to first clean aportion of the catheter 114 before cleaning the genitalia of the patientand/or clean the male shaft instead of the periphery about the malegenitalia.

As previously discussed, the package 124 may include the token 126. Thetoken 126 may be removed from the package 124 and attached to one of theindicator sites 122 (e.g., compliance indicator sites). Referring toFIG. 1B, the indicator element 104 is considered to be in an activestate after the token 126 is removed from the package 124 and attachedto an indicator site 122. For example, the indicator element 104verifies that the post-insertion patient care protocol has beenperformed at least three times during a two day period. However, theindicator element 104 may also illustrate that the indicator element 104does not verify that at least one post-insertion patient care protocolwas performed.

FIG. 1D is a top plan view of a package 124′ that may form a portion ofthe drainage bag system 100, according to an embodiment. Except asotherwise described herein, the package 124′ shown in FIG. 1D and itsrespective elements and components may be similar to or the same as thepackage 124 (FIG. 1C) and its respective elements and components.Additionally, the package 124′ illustrated in FIG. 1D may be used withor used instead of the package 124 illustrated in FIG. 1C in any of thedrainage bag systems disclosed herein.

The package 124′ may include a plurality of distinct labelings thereonthat facilitate performance and standardization of the post-insertionpatient care protocol. In the illustrated embodiment, the plurality ofdistinct labelings may include a first labeling 128 a, a second labeling128 b, and a third labeling 128 c. The first labeling 128 a may includegeneral information related to the package 124′, such as ingredientspresent in the package 124′. The second labeling 128 b may state how thewipes present in the package 124′ are to be used. For example, thesecond labeling 128 b may state that the first wipe present in thepackage 124′ may be used to clean a portion of the drainage bag system100 (e.g., the catheter 114 shown in FIG. 1A), the second wipe presentin the package 124′ may be used to clean a meatus of a male patient or afar-side of a meatus of a female patient, the third wipe present in thepackage 124′ may be used to clean a shaft of the male patient or anear-side of the meatus of the female patient, and the fourth and fifthwipes present in the package 124′ may be used to clean both inner thighregions of the patient. The second labeling 128 b may include pictures(e.g., photographs, drawings, schematics, etc.) and/or words to conveyhow the wipes present in the package 124′ are to be used. The thirdlabel 128 c may state how the package 124′ (e.g., not just the wipespresent in the package 124′) is to be used. For example, the third label128 c may state that the package 124′ may be configured for singlepatient use, that the wipes present in the package 124′ are to be usedaccording to the second labeling 128 b, that proper hand hygiene is tobe performed before using the package 124′, that hospital protocols areto be followed, a token 126′ present on and/or in the package 124′ is tobe placed onto an indicator element, that the wipes present in thepackage 124′ are not to be flushed down a toilet, etc.

In an embodiment, one or more of the first labeling 128 a, the secondlabeling 128 b, or the third labeling 128 b may be used on the package124 shown in FIG. 1C instead of the labeling 128. In an embodiment, oneor more of the first labeling 128 a, the second labeling 128 b, or thethird labeling 128 b may be omitted from the package 124′. In anembodiment, the package 124′ may include one or more additionallabelings thereon. In an embodiment, all of the labels are placed on thesame surface of the package 124′. In an embodiment, at least one of thelabels are placed on a different surface of the package 124′. Forexample, at least one of the labels is placed on a front surface of thepackage 124′ and at least one of the labels is placed on a back surfaceof the package 124′.

FIG. 2 is a top plan view of a drainage bag system 200 that includes adrainage bag 202 with a plurality of indicator elements (e.g., twoindicator elements), according to an embodiment. The drainage bag 202may be similar to the drainage bag 102 shown in FIG. 1A. For example,the drainage bag 202 may be in fluid communication with a catheter 214.As mentioned above, the drainage bag 202 may include any suitable numberof indicator elements. In the illustrated embodiment, the drainage bag202 includes a first indicator element 204 a and second indicatorelement 204 b. However, the drainage bag 202 may include more or fewerthan two indicator elements.

The first indicator element 204 a may include a first type identifier220 a that may be marked by a user in any manner described above. In theillustrated embodiment, the first indicator element 204 a also includesa display 230 (e.g., digital display) that provides or displaysinformation to the user. The first indicator element 204 a may alsoinclude one or more inputs 232 that may allow the user to interact withthe first indicator element 204 a. The inputs 232 may also allow theuser to input any number and/or type of suitable information into thefirst indicator element 204 a. For example, the inputs 232 may be usedto input the insertion date of the catheter or other general informationrelated to the drainage bag system 200 and/or patient care. As such, thedisplay 230 may be a type identifier and, in some embodiments, the firsttype identifier 220 a may be omitted. In another embodiment, the inputs232 may be used to verify compliance with the one or more patient careprotocols. As such, the display 230 may be an indicator site, such as acompliance indicator site. In particular, the display 230 may beinactive (e.g., the display 230 is blank (e.g., a blank location) anddoes not display information indicating (e.g., verifying) compliancewith patient care protocols) and may be activated using the inputs 232.In some embodiments, the display 230 may be both a type identifier andan indicator site (e.g., compliance indicator site). In someembodiments, the first indicator element 204 a may also include thedisplay 230 and one or more indicator sites similar to any of theindicator sites disclosed herein.

In some embodiments, the first indicator element 204 a may include atimer which may use the display 230 to show a time passed from an eventand/or time left to an event. The event may include any act that isrelated to the drainage bag system 200. For example, the event mayinclude the insertion of the catheter 114, the performance of one ormore patient care protocols (e.g., the post-insertion patient careprotocol), etc. In some embodiments, the user may use the one or moreinputs 232 to indicate when an event occurred. For example, the user mayuse the one or more inputs 232 to enter a time, reset the timer, startthe time, stop or pause the timer, etc. The first type identifier 220 amay indicate the event that the display 230 is counting from and/ortowards. In an embodiment, the digital display 230 may include memorythat stores one or more instructions thereon and a processor thatexecutes the one or more instructions stored on the memory. The user mayinput instructions into the digital display 230 using the inputs 232.The instructions may include when an event is to occur, what eventoccurred, or combinations thereof.

It should be appreciated that the timer may include any suitable timer,which may vary from one embodiment to the next. In some embodiments, thetimer may be an electronic timer, which may be autonomously powered(e.g., may include one or more batteries or similar power supplysources) or may be connected to an external power supply (e.g.,electrical outlet). Additionally or alternatively, the timer may includea mechanical mechanism that may be operated to change the time/datedisplayed to a user (e.g., wound to operate the display 230).Furthermore, in some embodiments, the timer may be controlled oroperated by a chemical reaction (e.g., a chemical reaction mayprogressively cause or result in a change in color along a time and/ordate scale, thereby indicating time elapsed after initiation of suchreaction, which may be caused by user input).

In some embodiments, the first indicator element 204 a may be removableand/or replaceable. For example, a user may remove the first indicatorelement 204 a from the drainage bag 202 when replacing the drainage bag202 and may place the first indicator element 204 a on a new drainagebag. Alternatively or additionally, the user may attach the firstindicator element 204 a to any suitable location near the drainage bag202. Moreover, any of the indicator elements described herein may beremovable and/or replaceable.

In some embodiments, the first indicator element 204 a may be configuredto be tamper resistant and/or minimize falsification. For example, thefirst indicator element 204 a may require a code before a user may inputany information into the first indicator element 204 a. In anembodiment, the code may be located inside a package. Alternatively, thecode may be unique to the user thereby identifying the user.

The second indicator element 204 b may include a second type identifier220 b that may receive input from a user in any manner described above.In the embodiment, the second indicator element 204 b may also include alist or checklist 223. The list or checklist 223 may be at leastpartially formed from one or more second indicator sites 222 b that maybe substantially similar to any of the indicator sites disclosed herein.For example, the second indicator sites 222 b may each initially includea blank or unfiled location configured to be marked by the user in anymanner described therein. The list or checklist 223 may include secondindicator sites 222 b that do not correspond to a certain time or date.For example, the list or checklist 223 may be used when the one or morepatient care protocols do not need to be performed at a certain time ordate, when the second indicator sites 222 b are configured to receiveinput that is configured to convey a time or date (e.g., each tokencorresponds to a date), when at least some of the second indicator sites222 b verify compliance with different patient care protocols (e.g.,compliance indicator sites), etc.

While the first indicator element 204 a and the second indicator element204 b are illustrated as including the display 230 and the list orchecklist 223, respectively; it is understood that the first indicatorelement 204 a and/or the second indicator element 204 b may include anyindicator element disclosed herein. For example, the first indicatorelement 204 a and the second indicator element 204 b may besubstantially the same. Additionally, the drainage bag system 200 mayfurther include more than two indicator elements. Moreover, as describedabove, one, some, or all of the indicator elements 204 a, 204 b may betamper resistant.

As discussed above, the drainage bag system 200 may include an indicatorelement (e.g., the first indicator element 204 a and/or the secondindicator element 204 b) thereon configured to verify compliance withone or more patient care protocols. For example, the indicator elementmay be configured to be marked using a writing utensil and/or a tokenthat is associated with a package (e.g., the package 124, 124′ shown inFIGS. 1C-1D). In some embodiments, the package may facilitateperformance of one or more patient care protocols pre-insertion and/orpost-insertion of a catheter. For example, a package that facilitatesperformance of one or more patient care protocols pre-insertion includesa kit, such as a Foley catheterization kit. In some embodiments, thewriting utensil and/or token may be located in the kit.

For example, FIG. 3 is a top plan view of a kit 334 that includes adrainage bag 302 and one or more tokens 326, according to an embodiment.For example, the drainage bag 302 may include an indicator element 304thereon that includes a type identifier 320 and/or one or more indicatorsites 322. As described above, the one or more indicator sites 322 maybe configured to have one or more tokens (e.g., token 326 and/or 326′)attached thereto, thereby indicating compliance with one or more patientcare protocols (e.g., compliance indicator sites). The kit 334 mayinclude a catheter (not shown, obscured under drainage bag 302) and adrainage tube 312 connected or connectable to the drainage bag 302. Insome embodiments, the kit 334 may be a Foley catheterization kit thatmay include sterile water 336 to inflate a balloon of the catheter,lubrication gel 338, one or more swabs 340, an antiseptic, at least oneother suitable apparatus or device, or combinations of the foregoing. Insome embodiments, the kit 334 may include a package 324 therein thatthat is used to perform one or more patient care protocols pre-insertionor post-insertions (e.g., the package 124, 124′ shown in FIGS. 1C-1D).The package 324 may include at least one token 326 associated therewithor the token 326 associated with the package 324 may be omitted.

In an embodiment, the kit 334 may include a token 326 located in a tray342 of the kit 334. For example, the token 326 may be accessed after thecompletion of one or more tasks related to the patient care and/orcompliance with one or more patient care protocols displayed on theindicator element 304. The token 326 (e.g., the token located on thepackage 324 and/or the token located in the tray 342) may verifyperformance and/or compliance of a pre-insertion patient care protocol.More particularly, for example, the pre-insertion patient care protocolmay include one or more of cleaning the catheter, the meatus of thepatient, or the inner thighs of the patient using wipes present in thepackage 324 prior to insertion of the catheter into the patient.

In an embodiment, the token 326 located in the tray 342 may be locatedunder the drainage bag 302. As such, the token 326 may be accessed afterthe drainage bag 302 is removed from the kit 334. Alternatively, thetoken 326 may be located at a number of other suitable locations in oron the tray 342 of the kit 334 (e.g., under the sterile water 336) orpositioned on one or more components contained within the kit 334 (e.g.,the sterile water 336, etc.). Additionally, marking the indicatorelement 304 using the token 326 within the kit 334 may indicate that theuser marked the indicator element 304 at a time between opening anddisposing the kit 334.

In some embodiments, the token 326 may be associated with a particularpatient care protocol performed. For example, the kit 334 may include aplurality of tokens 326 therein that correspond to different patientcare protocols. As such, the token 326 may include text, graphics,color, etc., which may associate the token 326 with the particularpatient care protocol. Also, the token 326 may be located in any numberof suitable kits or locations, which may be accessed during and/or afterperforming the particular patient care protocols.

In some embodiments, a separate pre-insertion patent care package may beincluded in the kit 334 and include its own corresponding one or moretokens to indicate performance and/or compliance of one or morepre-insertion patient care protocols including one or more of cleaningthe catheter, the meatus of the patient, or the inner thighs of thepatient using wipes present in the pre-insertion patent care packageprior to insertion of the catheter into the patient. These separate oneor more tokens from the pre-insertion patent care package may be appliedto the indicator element 304 in a selected location to indicateperformance and/or compliance of the one or more pre-insertion patientcare protocols. As such, marking the indicator element 304 using thetoken may indicate that a specific task was completed (e.g., verifyingthat a pre-insertion and/or post-insertion patient care protocol wasperformed).

FIGS. 4A-4D are isometric views of indicator elements 404 that aredistinct and separate from (e.g., not attached or otherwise incorporatedinto) a drainage bag 402, according to various embodiments. Theindicator element 404 shown in FIGS. 4A-4D may be used in any of theembodiments disclosed herein.

The indicator elements 404 may be used in a drainage bag system 400 thatis substantially similar to the drainage bag system 100 shown in FIG.1A. For example, the drainage bag 402 may be configured to receive afluid from a patient via a drainage tube 412. The drainage bag system400 may also include at least one indicator element 404 that isconfigured to indicate that a task related to the drainage bag system100 was performed. For example, the indicator element 404 may include acompliance indicator element configured to verify compliance with one ormore patient care protocols that are associated with the drainage bagsystem 400. Each indicator element 404 may include a type identifier 420and/or one or more indicator sites 422. Each indicator element 404 mayinclude a paper, plastic, other medium, or combinations thereof thatincludes the type identifier 420 and/or the indicator sites 422 thereon(e.g., printed thereon).

Referring to FIG. 4A, the indicator element 404 may be configured toattach to one or more components of the drainage bag system 400. Forexample, the indicator element 404 is attached to one or more componentsof the drainage bag system 400 that are distinct and separate from thedrainage bag 402, such as a drainage tube 412. Alternatively, the one ormore components of the drainage bag system 400 may include a portion ofthe drainage bag 402 that is distinct and separate from the front panel406, such as an inlet 410 of the drainage bag 402, an outlet 416 of thedrainage bag 402, etc. The indicator element 404 may attach to the oneor more components of the drainage bag system 400 using an adhesive, astring, an elastic band, a clamp, or another attachment method. Forexample, the indicator element 404 may include a hole 446 therein thatreceives the string, elastic band, or other attachment device.Alternatively, the hole 446 may receive the one or more components ofthe drainage bag system 400 (e.g., a portion of the drainage tube 412may be positioned within the hole 446) or the hole 446 may be omitted.Similarly, the one or more components of the drainage bag system 400 maybe configured to have the indicator element 404 attached thereto. Forexample, the one or more components of the drainage bag system 400 maycomprises a stronger material or be thicker than similar portions of thedrainage bag system 400.

Referring to FIG. 4B, the indicator element 404 may be configured to beattach to one or more medical devices proximate to the drainage bagsystem 400. For example, the illustrated indicator element 404 isattached to an IV pole 444. The indicator element 404 may attach to theone or more medical devices using any of the attachment method disclosedherein.

Referring to FIG. 4C, the indicator element 404 may be configured to beattached to a bed 448. For example, the indicator element 404 may beattached to the bed 448 on which a patient is positioned. The indicatorelement 404 may be attached to any portion of the bed 448, such as abase of the bed 448. The indicator element 404 may be attached to thebed 448 using any of the attachment methods disclosed herein.

Referring to FIG. 4D, the indicator element 404 may be configured to beattached to a wall 450. For example, the indicator element 404 may beattached to one of the walls 450 that encloses a room in which thedrainage bag system 400 is positioned. The indicator element 404 may beattached to the wall 450 using any of the attachment techniques and/ordevices disclosed herein.

In an embodiment, the indicator element 404 may distinct and separatefrom the drainage bag 402 to improve the visibility of the indicatorelement 404 from one or more locations. For example, the drainage bag402 may be at least partially obscured from one or more locations (e.g.,the door to the patient's room, the base of the bed 448, etc.). As such,the indicator element 404 may be spaced from the drainage bag 402 andattached to a location that improves the visibility of the indicatorelement 404 from one or more locations, such as any of the locationsdisclosed herein or any other suitable location.

FIG. 5 is a side view of a drainage bag system 500 including a drainagebag 502 and a plurality of packages 524 (e.g., the package 124, 124′shown in FIGS. 1C-1D) removably attached together, according to anembodiment. The plurality of packages 524 may be used with any of theembodiments disclosed herein.

The drainage bag 502 may be the same as or similar to the drainage bags102, 202, 302, 402 shown in FIGS. 1A, 2-4A. For example, the drainagebag 502 may include at least one indicator element 504 configured toverify completion of a task related to the drainage bag system 500. Inthe illustrated embodiment, the indicator element 504 includes a typeidentifier 520 and one or more indicator sites 522. The indicator sites522 may at least partially form a calendar 523. Each of the one or moreindicator sites 522 may include a blank or unfilled location that isconfigured to be marked by a user. For example, the one or moreindicator sites 522 may be marked by a user before, during, or after oneor more patient care protocols have been performed. In the illustratedembodiment, the indicator element 504 may include a compliance indicatorsites that may verify compliance with one or more patient care protocolsthat occur twice a day (e.g., every 12 hours).

In an embodiment, the drainage bag 502 may be configured to be attachedto an IV pole 544. For example, the drainage bag 502 may include a hook552 that attaches to the IV pole 544. Connecting the drainage bag 502 tothe IV pole 544 or another similar device may increase the visibility ofthe indicator element 504. However, the drainage bag 502 may be attachedto devices other than the IV pole 544 that are proximate the patient.For example, the drainage bag 502 may be attached to the patient, a bed,a wheelchair, a medical device, a wall, or any other suitable device.

The plurality of packages 524 may be removably attached together (e.g.,directly or indirectly). In the illustrated embodiment, the plurality ofpackages 524 are indirectly attached together used a retention device554. The retention device 554 may be attached to the IV pole 544 (e.g.,include a hook, hole, etc.). The retention device 554 may include anydevice that is configured to carry the plurality of packages 524 andpermit the packages 524 to be removed therefrom. For example, theretention device 554 may include a rigid, semi-rigid, or flexiblematerial. Each of the plurality of packages 524 may be attached to theretention device 554 using adhesives (e.g., both weak and strongadhesives), clamps, or any other attachment technique. In an embodiment,each of the plurality of packages 524 may be removably attached to theretention device 554, thereby allowing each of the plurality of packages524 to be selectively detached from the retention device 554 and fromeach other. For example, in the illustrated embodiment, the retentiondevice 554 may define a plurality of holes 556 that can receive theplurality of packages 524. In another embodiment, the plurality ofpackages 524 may be attached to the retention device 554 using a weakadhesive or other reversible attachment technique. In anotherembodiment, each of the plurality of packages 524 may more stronglyattached (e.g., using a strong adhesive, a staple, etc.) to theretention device 554. For example, in such an embodiment, detaching oneof the plurality of packages 524 from the rest of the packages 524 alsorequires separating some of the retention device 554 from the rest ofthe retention device 554. As such, the retention device 554 may includea plurality of perforations or other mechanism that permits a portion ofthe retention device 554 to be separated from the rest of the retentiondevice 554.

In an embodiment, the plurality of packages 524 may be directlyremovably attached together. For example, the plurality of packages 524are removably attached together using an adhesive that is strong enoughto hold the plurality of packages 524 together, but weak enough to alloweach of the plurality of packages 524 to be detached without damagingthe any of the plurality of packages 524. In another embodiment, each ofthe plurality of packages 524 may be bonded together. In such anexample, the boundary between each of the plurality of packages 524 mayinclude a plurality of perforations that allow a user to easily separateone package 524 from an immediately adjacent package 524. In anembodiment, the plurality of packages 524 may be removably attached toeach other and to the retention device 554.

The plurality of packages 524 may be configured to verify compliancewith one or more patient care protocols. For example, detaching one ofthe plurality of packages 524 from the rest of the plurality of packages524 may indicate that one or more patient care protocols associated withthe packages 524 has been performed. A compliance officer (e.g., asupervisor, responsible physician, etc.) may view the plurality ofpackages 524 and see that at least one package 524 is missing, therebyindicating that the one or more patient care protocols associated withthe package 524 were performed.

In an embodiment, the plurality of packages 524 may be used inconjunction with the indicator element 504 of the drainage bag 502. Forexample, each of the plurality of packages 524 may include at least onetoken associated therewith (e.g., attached thereto, incorporatedtherewith, or positioned therein). In some embodiments, the token mayonly be accessed after the package 524 is detached from the rest of theplurality of packages 524. As such, the plurality of packages 524 mayform a second means of indicating compliance with the one or morepatient care protocols.

While various aspects and embodiments have been disclosed herein, otheraspects and embodiments are contemplated. The various aspects andembodiment disclosed herein are for purposes of illustration and are notintended to be limiting.

What is claimed:
 1. A patient care protocol package, comprising: acontainer; one or more wipes disposed in the container, the one or morewipes for use in performing one or more patient care protocols; and atleast one labeling provided on the container, the at least one labelingfacilitates correct usage of the one or more wipes and facilitatescorrect performance of the one or more patient care protocols.
 2. Thepatient care protocol package of claim 1, wherein the one or morepatient care protocols include one or more catheter post-insertionpatient care protocols.
 3. The patient care protocol package of claim 1,wherein the at least one labeling includes: a first portion thatfacilitates correct usage of the one or more wipes and facilitatescorrect performance of one or more female patient care protocols; and asecond portion that facilitates correct usage of the one or more wipesand facilitates correct performance of one or more male patient careprotocols.
 4. The patient care protocol package of claim 3, wherein thefirst and second portions of the at least one labeling are in the formof distinct columns.
 5. The patient care protocol package of claim 1,wherein the at least one labeling includes at least one of words orpictures.
 6. The patient care protocol package of claim 5, wherein theat least one labeling includes a first labeling that includes thepictures and a second labeling spaced from the first labeling thatincludes substantially only words.
 7. The patient care protocol packageof claim 1, wherein the container includes at least one flap, the atleast one labeling is positioned adjacent to the flap.
 8. The patientcare protocol package of claim 1, further comprising: at least one tokendisposed in or on the container, the at least one token configured to beremoved from the container; wherein the at least one token at least oneof performs, verifies, or assists with the one or more patient careprotocols.
 9. The patient care protocol package of claim 8, wherein theat least one token is positioned on an exterior surface of thecontainer.
 10. The at least one patient care protocol package of claim8, wherein the at least one token includes a sticker.
 11. A patient careprotocol package, comprising: a container including at least one flap;one or more wipes disposed in the container, the one or more wipes foruse in performing one or more patient care protocols; at least onelabeling provided on the container adjacent to the flap, the at leastone labeling including a first column and a second column, each of thefirst and second columns includes at least one picture; wherein thefirst column facilitates correct usage of the one or more wipes andfacilitates correct performance of the one or more patient careprotocols with regards to female anatomy; wherein the second columnfacilitates correct usage of the one or more wipes and facilitatescorrect performance of the one or more patient care protocols withregards to male anatomy; and at least one token disposed on thecontainer, the at least one token including a sticker that is configuredto be removed from the container; wherein the at least one token atleast one of performs, verifies, or assists with the one or more patientcare protocols.
 12. A patient care protocol system, comprising: adrainage bag including: an inlet configured to receive a fluid from apatient; and one or more panels defining an interior space configured tohold the fluid therein; at least one indicator element including one ormore indicator sites thereon, each of the one or more indicator sitesincluding at least one of a blank or unfilled location; and at least onepatient care protocol package including: a container; one or more wipesdisposed in the container, the one or more wipes for use in performingone or more patient care protocols; and at least one labeling providedon the container, the at least one labeling facilitates correct usage ofthe one or more wipes and facilitates correct performance of the one ormore patient care protocols.
 13. The patient care protocol system ofclaim 12, wherein the at least one indicator element is attached to thedrainage bag.
 14. The patient care protocol system of claim 12, whereinthe at least one indicator element is integrally formed with thedrainage bag.
 15. The patient care protocol system of claim 12, whereinthe at least one patient care protocol package includes at least onetoken associated therewith, the one or more indicator sites areconfigured to be marked with the at least one token.
 16. The patientcare protocol system of claim 15, wherein the at least one token ispositioned on an exterior surface of the container.
 17. A method ofusing at least one patient care protocol package, the method comprising:removing one or more wipes from a container, the one or more wipesconfigured to perform one or more patient care protocols; consulting atleast one labeling provided on the container, the labeling facilitatingcorrect usage of the one or more wipes and correct performance of theone or more patient care protocols; and after consulting the at leastone labeling, performing the one or more patient care protocols on apatient with the one or more wipes in accordance with the at least onelabeling.
 18. The method of claim 17, wherein the one or more patientcare protocols include one or more catheter post-insertion patient careprotocols.
 19. The method of claim 17, wherein performing the one ormore patient care protocols includes cleaning at least one inner thighof the patient with at least one of the one or more wipes in accordancewith the at least one labeling.
 20. The method of claim 17, whereinperforming the one or more patient care protocols includes cleaning ameatus and/or a periphery about the meatus of the patient with at leastone of the one or more wipes in accordance with the at least onelabeling.
 21. The method of claim 17, wherein performing the one or morepatient care protocols includes cleaning at least a portion of acatheter that is inserted into the patient with at least one of the oneor more wipes in accordance with the at least one labeling.
 22. Themethod of claim 17, further comprising removing at least one token thatis disposed in or on the container from the container, the at least onetoken at least one of performs, verifies, or assists at least one of theone or more patient care protocols that use the at least one patientcare protocol package.
 23. The method of claim 22, further comprisingadhering the at least one token to a drainage bag that is fluidlycoupled to the patient.